Online screening for mental health in children with heart defects
Official title: Mind the Heart - Mental Health in Children and Adolescents With Congenital Heart Defects in Denmark
Run by Copenhagen University Hospital, Rigshospitalet · NCT05709470 · Data updated 2026-11-12
This study is testing an online screening tool to see if it can help identify mental health issues in children with heart defects and provide families with useful information and support.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 5 Years to 17 Years |
| Sex | All |
| Enrollment | 4800 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | March 17, 2023 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | September 26, 2025 |
| Trial ID | NCT05709470 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Danish children and adolescents aged 5-18 years who have been diagnosed with a congenital heart defect.
✕Probably not a fit
Patients younger than 5 years or older than 18 years, or those lacking sufficient Danish language skills, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The Mind the Heart initiative aims to assess the feasibility of an online screening model for mental disorders in Danish children and adolescents diagnosed with congenital heart disease. The study will involve parents completing online questionnaires regarding their child's mental health and psychological support received. Children aged 11 and older will also participate in standardized assessments to evaluate the likelihood of psychiatric diagnoses. The results will be reviewed by trained clinicians, and families will receive a summary report within three months. Additionally, a website will be developed to provide evidence-based information on mental health for families and healthcare professionals.
Why it matters
Potential benefit: If successful, this study could lead to improved identification and treatment of mental health issues in children with congenital heart defects.
How similar studies have gone: Other studies have shown success in using online screening tools for mental health assessments in pediatric populations, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Born with a Congenital Heart Defect * Age 5-17y * (Living in Denmark) Exclusion Criteria: * Younger than 5years of age * Older than 17years of age * Lacking sufficient Danish language skills to answer the questionnaire
Where it's running
-
Department of cardiothoracic surgery, Rigshospitalet
Copenhagen, Denmark Recruiting
Study contacts
- Study coordinator: Sara H Lau Jensen, M.D.
- Email: sara.hirani.lau-jensen@regionh.dk
- Phone: 004526192879
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.